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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020717
Company: CEPHALON

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVIGIL MODAFINIL 100MG TABLET;ORAL Prescription AB Yes No
PROVIGIL MODAFINIL 200MG TABLET;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/15/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
01/15/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
10/21/2010 SUPPL-36 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-34 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
08/17/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
08/17/2007 SUPPL-18 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
08/17/2007 SUPPL-13 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
01/23/2004 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-008_provigil_lbl.pdf
12/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf
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